Benzodiazepine DeprescribingEND-IT CSNCT05929417
Benzodiazepines Deprescribing in the Community Setting: Intervention Feasibility
A study testing END-IT intervention for the community setting in people with Benzodiazepine Deprescribing, run by Université Catholique de Louvain at 1 site in Belgium.
Trial summary
The goal of this feasibility study is to evaluate the feasibility of an intervention, led by the pharmacist, aiming at benzodiazepines and z-drugs deprescribing in older adults living in the Belgian community setting. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Benzodiazepine Deprescribing
- What is being tested?
- END-IT intervention for the community setting
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteBelgium
- Study dates
- 23 May 2023to Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- being aged ≥65 years,
- taking a benzodiazepine receptor agonist for ≥4 weeks (Anatomical Therapeutic Chemical codes: N05BA, N05CD, N05CF and N03AE01)
- being a regular patient of the community pharmacy (defined as ≥ 4 visits/12 previous months).
Who cannot join
- Severe mental illness (assessed through having an active prescription of any antipsychotic medication).
- Dementia or significant cognitive impairment (assessed through an active prescription or any past prescription during the last 12 months of anticholinesterase inhibitors or memantine) and/or pharmacist's judgment).
- Patients unable to read or communicate in French.
- Ongoing benzodiazepine receptor agonist withdrawal at the time of recruitment.
- Known current alcohol withdrawal.
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
UCLouvain
Woluwe-Saint-Lambert, 1200
Catherine Pétein, MPH, +3227647236, catherine.petein@uclouvain.be
About this study
Official title: Feasibility of a Benzodiazepine Deprescribing Intervention in Older Adults Living in the Belgian Community Setting
The goal of this feasibility study is to evaluate the feasibility of an intervention, led by the pharmacist, aiming at benzodiazepines and z-drugs deprescribing in older adults living in the Belgian community setting. The main questions it aims to answer are:
- To what extent will Belgian community pharmacists adhere to the intervention?
- To what extent will patients and general practitioners take up the intervention to deprescribe benzodiazepines and z-drugs?
- To what extent is the design of the recruitment and data collection process feasible and acceptable for all participants?
Read more
Participants will receive an educational brochure from their pharmacist. Their pharmacist will also propose to send a new standardized form to their general practitioner to enhance collaboration about a potential benzodiazepine deprescribing.
Researchers will compare this intervention to usual care to see if the intervention is feasible and to gather first data on intervention effectiveness in benzodiazepine deprescribing.
- Conditions
- Benzodiazepine Deprescribing
- Being tested
- END-IT intervention for the community setting
- Keywords
- Benzodiazepines, Deprescribing, Community setting, Older adults
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
END-IT intervention for the community settingOther
The intervention was described in the arm/group descriptions.
| Study group | Role | What they receive |
|---|---|---|
| END-IT intervention for the community setting | Experimental | The community pharmacist will distribute an educational brochure to the patient. He will also propose to the patient to communicate about a potential benzodiazepine deprescribing with his/her general practitioner through a document called pharmaceutical proposal. Receives: Other: END-IT intervention for the community setting |
| Control | No intervention | The participants will receive the usual care. The community pharmacists allocated to the control group will have access to the intervention material at the end of the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacists' adherence to the intervention
Has the intervention been implemented as intended? (e.g: global number of implemented intervention components)
Measured: At 3 months
Pharmacists' adherence to the intervention
Has the intervention been implemented as intended? (e.g: global number of implemented intervention components)
Measured: At 6 months
Participants' responsiveness
How far participants (pharmacists, patients, and general practitioners) have responded to the intervention and have been engaged by the intervention: e.g. number of altered prescriptions).
Measured: At 3 months
Participants' responsiveness
How far participants (pharmacists, patients, and general practitioners) have responded to the intervention and have been engaged by the intervention: e.g. number of altered prescriptions).
Measured: At 6 months
Feasibility of the recruitment process
The feasibility of the recruitment will be assessed (e.g. the ratio between the number of included patients and patients contacted for participation).
Measured: At 6 months
Feasibility of the data collection process
The feasibility of the data collection process will be assessed through the quality of the collected data (rate of missing data).
Measured: At 6 months
Secondary outcomes (7)
Contextual factors potentially influencing the intervention effects at the patient-level.
Use of a questionnaire to assess factors that could explain potential differences in intervention implementation between patients.
Measured: At baseline
Contextual factors potentially influencing the intervention effects at the pharmacist-level.
Use of a questionnaire to assess factors that could explain potential differences in intervention implementation between pharmacies.
Measured: At baseline
Mechanisms of impact potentially influencing the intervention
Use a questionnaire to assess mechanisms of impact in relation with how the intervention is supposed to have its effects.
Measured: At baseline
Mechanisms of impact potentially influencing the intervention
Use of a questionnaire to assess mechanisms of impact in relation with how the intervention is supposed to have its effects.
Measured: At 3 months
Mechanisms of impact potentially influencing the intervention
Use of a questionnaire to assess mechanisms of impact in relation with how the intervention is supposed to have its effects.
Measured: At 6 months
Exploratory benzodiazepine deprescribing rate analysis
Defined as benzodiazepine reduction or cessation at 6 months
Measured: At 3 months
Exploratory benzodiazepine deprescribing rate analysis
Defined as benzodiazepine reduction or cessation at 6 months
Measured: At 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start23 May 2023
- Primary completionJan 2024 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Benzodiazepine DeprescribingStudies of the same condition, open and under way.
- More trials run by Université Catholique de LouvainThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université Catholique de Louvain
- Sponsor type
- University, hospital or other
- Collaborators
- EBPracticenet, Fonds National de la Recherche Scientifique
- Responsible party
- Sponsor
- Investigators
- Anne Spinewine, PhD, Principal investigator, UCLouvain, Louvain Drug Research Institute/Clinical pharmacy research group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05929417
- Sponsor's protocol ID
- CLIP/2023/01
- Acronym
- END-IT CS
- Status last verified
- Jun 2023
- First submitted
- 23 May 2023
- Last updated
- 3 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only publishable project data relating to the main analysis and research output will be shared on a data repository after an embargo period of 2 years after June 2024. All relevant documentation necessary to facilitate data re-use will be shared along with the datasets.
Publications
Petein C, Chevallereau T, Aikpitanyi J, Evrard P, Tubeuf S, Henrard S, Spinewine A. Protocol to evaluate the feasibility of the D-PRESCRIBE intervention adapted to the Belgian community setting (END-IT CS study). BMJ Open. 2025 Mar 4;15(3):e085434. doi: 10.1136/bmjopen-2024-085434.
PubMed 40037665
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of a Benzodiazepine Deprescribing Intervention in Older Adults Living in the Belgian Community Setting
- ClinicalTrials.gov ID
- NCT05929417
- Acronym / sponsor ID
- END-IT CS / CLIP/2023/01
- Conditions
- Benzodiazepine Deprescribing
- Keywords
- Benzodiazepines, Deprescribing, Community setting, Older adults
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Université Catholique de LouvainUniversity, hospital or other
- Collaborators
- EBPracticenet, Fonds National de la Recherche Scientifique
- Study start
- 23 May 2023 (actual)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 3 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this feasibility study is to evaluate the feasibility of an intervention, led by the pharmacist, aiming at benzodiazepines and z-drugs deprescribing in older adults living in the Belgian community setting. The main questions it aims to answer are:
- To what extent will Belgian community pharmacists adhere to the intervention?
- To what extent will patients and general practitioners take up the intervention to deprescribe benzodiazepines and z-drugs?
- To what extent is the design of the recruitment and data collection process feasible and acceptable for all participants?
Participants will receive an educational brochure from their pharmacist. Their pharmacist will also propose to send a new standardized form to their general practitioner to enhance collaboration about a potential benzodiazepine deprescribing.
Researchers will compare this intervention to usual care to see if the intervention is feasible and to gather first data on intervention effectiveness in benzodiazepine deprescribing.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| END-IT intervention for the community setting | Experimental | Other: END-IT intervention for the community settingThe community pharmacist will distribute an educational brochure to the patient. He will also propose to the patient to communicate about a potential benzodiazepine deprescribing with his/her general practitioner through a document called pharmaceutical proposal. |
| Control | No intervention | –The participants will receive the usual care. The community pharmacists allocated to the control group will have access to the intervention material at the end of the study. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- being aged ≥65 years,
- taking a benzodiazepine receptor agonist for ≥4 weeks (Anatomical Therapeutic Chemical codes: N05BA, N05CD, N05CF and N03AE01)
- being a regular patient of the community pharmacy (defined as ≥ 4 visits/12 previous months).
Key exclusion criteria (5 listed)
- Severe mental illness (assessed through having an active prescription of any antipsychotic medication).
- Dementia or significant cognitive impairment (assessed through an active prescription or any past prescription during the last 12 months of anticholinesterase inhibitors or memantine) and/or pharmacist's judgment).
- Patients unable to read or communicate in French.
- Ongoing benzodiazepine receptor agonist withdrawal at the time of recruitment.
- Known current alcohol withdrawal.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| END-IT intervention for the community settingThe intervention was described in the arm/group descriptions. | Other | END-IT intervention for the community setting |
Primary outcome
Pharmacists' adherence to the intervention
Time frame: At 3 months
Has the intervention been implemented as intended? (e.g: global number of implemented intervention components)
Pharmacists' adherence to the intervention
Time frame: At 6 months
Has the intervention been implemented as intended? (e.g: global number of implemented intervention components)
Participants' responsiveness
Time frame: At 3 months
How far participants (pharmacists, patients, and general practitioners) have responded to the intervention and have been engaged by the intervention: e.g. number of altered prescriptions).
Participants' responsiveness
Time frame: At 6 months
How far participants (pharmacists, patients, and general practitioners) have responded to the intervention and have been engaged by the intervention: e.g. number of altered prescriptions).
Feasibility of the recruitment process
Time frame: At 6 months
The feasibility of the recruitment will be assessed (e.g. the ratio between the number of included patients and patients contacted for participation).
Feasibility of the data collection process
Time frame: At 6 months
The feasibility of the data collection process will be assessed through the quality of the collected data (rate of missing data).
7 secondary outcomes
Contextual factors potentially influencing the intervention effects at the patient-level.
Time frame: At baseline
Contextual factors potentially influencing the intervention effects at the pharmacist-level.
Time frame: At baseline
Mechanisms of impact potentially influencing the intervention
Time frame: At baseline
Mechanisms of impact potentially influencing the intervention
Time frame: At 3 months
Mechanisms of impact potentially influencing the intervention
Time frame: At 6 months
Exploratory benzodiazepine deprescribing rate analysis
Time frame: At 3 months
Exploratory benzodiazepine deprescribing rate analysis
Time frame: At 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2023.
- Derived from this study: PubMed 40037665Petein C, Chevallereau T, Aikpitanyi J, Evrard P, Tubeuf S, Henrard S, Spinewine A. Protocol to evaluate the feasibility of the D-PRESCRIBE intervention adapted to the Belgian community setting (END-IT CS study). BMJ Open. 2025 Mar 4;15(3):e085434. doi: 10.1136/bmjopen-2024-085434.
- Individual participant dataSharing planned: No. Only publishable project data relating to the main analysis and research output will be shared on a data repository after an embargo period of 2 years after June 2024. All relevant documentation necessary to facilitate data re-use will be shared along with the datasets.
Related trials for Benzodiazepine Deprescribing
Active, not recruiting
Improving Patient Safety by Supporting Older Adults in Managing Sleep Problems.
Benzodiazepines Deprescribing, Sleep Problems
Recruiting
Effectiveness of a Joint General Practitioner-Pharmacist Intervention on Benzodiazepine Deprescribing in the Elderly
Primary Care, Health Plan Implementation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne Spinewine, PhD principal investigator
UCLouvain, Louvain Drug Research Institute/Clinical pharmacy research group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing END-IT intervention for the community setting in people with Benzodiazepine Deprescribing, run by Université Catholique de Louvain at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Catherine Pétein, RN, MPH (+3227647236, catherine.petein@uclouvain.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacists' adherence to the intervention (time frame: At 3 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05929417, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2023; AzTrials last refreshed its copy on 6 Nov 2026.